Tafasitamab, Lenalidomide, and Venetoclax for Relapsed/Refractory Mantle Cell Lymphoma
This study is testing a combination of three medications – tafasitamab, lenalidomide, and venetoclax – for people with mantle cell lymphoma that has returned (relapsed) or hasn't responded to previous treatments (refractory). Tafasitamab is a monoclonal antibody that may help stop cancer cells from growing. Lenalidomide works by boosting your immune system to fight cancer. Venetoclax aims to block a protein called Bcl-2 that cancer cells need to survive. The main goal is to see how many patients respond to this treatment. You may be eligible if you are 18 or older and have a confirmed diagnosis of mantle cell lymphoma.
- Study design
- This is an interventional study planning to enroll 100 participants. The specific phase of the study is not specified.
- What's involved
- You would undergo procedures such as a biopsy, blood sample collection, bone marrow aspiration, bone marrow biopsy, and CT scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured for up to 5 years.
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NCT05910801
Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentAcademic and Community Cancer Research UnitedInvestigator-initiated
~100 participants
Updated 2024-11-18 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyComputed TomographyLenalidomide
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate
Measured over Up to 5 years
Conditions
Where it's being run
2 sites across 2 statesMinnesota1
Texas1
Study leadership
- Yucai Wang · PRINCIPAL_INVESTIGATOR · Academic and Community Cancer Research United
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age \>= 18 years old
Confirmed pathology diagnosis of mantle cell lymphoma (MCL) with t(11;14)(q13;q32) translocation or cyclin D1 overexpression NOTE: Patients with relapsed/refractory MCL after prior anti-CD19 therapy (such as chimeric antigen receptor \[CAR\] T-cell therapy) should have confirmed preserved expression of CD19, unless a biopsy is not feasible or associated with a high risk of complications in the treating physician's opinion
Relapsed or refractory disease, which is defined as patients with \>= 1 line of prior systemic treatment NOTE: Prior exposure to lenalidomide or venetoclax is allowed, provided there was no disease progression on lenalidomide or venetoclax
In the view of the treating physician, the patient is in need of treatment, for example, with lymphoma-related symptoms or cytopenia
Evaluable disease, which is defined as at least one lymph node or other type of lesion that has a size \>= 1.5 cm, or spleen size \>= 15 cm or white blood cell (WBC) \>= 30,000/mm\^3 in leukemic non-nodal MCL patients
Eastern Cooperative Oncology Group Performance Status (PS) 0, 1, or 2
Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 14 days prior to registration)
Platelet count \>= 75,000/mm\^3 (\>= 50,000/mm\^3 if there is evidence of bone marrow involvement by MCL or hypersplenism) (obtained =\< 14 days prior to registration)
Hemoglobin \> 8.0 g/dL (obtained =\< 14 days prior to registration)
Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) =\< 1.5 × upper normal limit (ULN) (obtained =\< 14 days prior to registration)
Prothrombin (PT) or international normalized ratio (INR) =\< 1.5 × upper normal limit (ULN) (obtained =\< 14 days prior to registration)
Total bilirubin =\< 1.5 × ULN (or =\< 3 × ULN if there is evidence of parenchymal liver involvement with MCL or documented Gilbert's disease) (obtained =\< 14 days prior to registration)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 × ULN (or =\< 5 × ULN if there is evidence of parenchymal liver involvement with MCL) (obtained =\< 14 days prior to registration)
Calculated creatinine clearance \> 60 ml/min using the Cockcroft-Gault formula (obtained =\< 14 days prior to registration)
Negative pregnancy test done =\< 7 days prior to registration, for women of reproductive potential only NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required NOTE: Females of reproductive potential include all females who are menstruating, amenorrheic from previous medical treatments, under 50 years of age, and/or perimenopausal, and do not qualify for the females not of reproductive potential category. Females not of reproductive potential include females who have been in natural menopause for at least 24 consecutive months, or who have had a hysterectomy and/or bilateral oophorectomy, or female children who have not started menstruating
Agree to use effective contraception during study treatment and for 4 weeks after last dose of lenalidomide and for 3 months after last dose of tafasitamab (whichever is longer) Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control simultaneously: one highly effective form of contraception - tubal ligation, intrauterine device (IUD), hormonal (birth control pills, injections, hormonal patches, vaginal rings, or implants), or partner's vasectomy, and one additional effective contraceptive method - male latex or synthetic condom, diaphragm, or cervical cap. Contraception should continue during therapy, during dose interruptions, and for 4 weeks following discontinuation of lenalidomide and for 3 months after discontinuation of tafasitamab (whichever is longer). Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy. If needed, females of reproductive potential should be referred to a qualified provider of contraceptive methods Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential during trial therapy, during dose interruptions, and for 4 weeks following discontinuation of lenalidomide and for 3 months after discontinuation of tafasitamab (whichever is longer), even if they have undergone a successful vasectomy. Male patients must not donate sperm
Willing to be registered into the mandatory REVLIMID REMS (trademark) program, and willing and able to comply with the requirements of the REVLIMID REMS program
Able to take low-dose aspirin (81 mg) daily or an alternative form of anticoagulation
Subject must voluntarily sign and date an informed consent =\< 28 days prior to registration
Willing to return to enrolling institution for follow-up during the active monitoring phase (i.e., active treatment and clinical follow-up) of the study
Willing to provide mandatory blood specimens for correlative research and banking for future correlative research pertinent to this study
Exclusion
Any of the following:
Pregnant persons
Nursing persons (lactating persons are eligible provided that they agree not to use their breast milk to feed while receiving treatment on the study or within 3 months of the last dose of study treatment)
Men or women of reproductive potential who are unwilling to employ adequate contraception during treatment and for 4 weeks after last dose of lenalidomide or for 3 months after last dose of tafasitamab (whichever is longer)
Any of the following prior therapies:
Autologous stem cell transplant =\< 90 days prior to registration
Allogeneic stem cell transplant
Anti-CD19 CAR T-cell therapy =\< 90 days prior to registration
Any central nervous system (CNS) involvement by MCL (e.g., any parenchymal, leptomeningeal, cerebrospinal fluid \[CSF\], cranial or spinal nerve root involvement)
Receiving any other treatment which would be considered as a treatment for MCL (with the exception of corticosteroid). If a patient received recent MCL treatment prior to registration, at least 5 half-lives of the drug(s) OR 14 days must have passed following the last dose for the patient to be eligible
Any of the following medication requirement or recent use:
Anticoagulation with a vitamin K antagonist =\< 7 days prior to registration
Requirement of a P-gp inhibitor during the study
Requirement of a strong cytochrome P450 (CYP) 3A inhibitor or inducer during the study
Use of a strong or moderate CYP3A inhibitor or inducer =\< 7 days prior to registration
Grapefruit or grapefruit products
Seville oranges or products from Seville oranges
Star fruit
Human Immunodeficiency Virus (HIV) positive. All subjects will be screened for HIV =\< 14 days prior to registration
Patient with chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. All subjects will be screened for hepatitis B and hepatitis C =\< 14 days prior to registration NOTE: Patients with positive hepatitis B surface antigen (HBsAg) are excluded from participation in this trial. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation. Patients who are hepatitis B PCR positive will be excluded from participating in this trial NOTE: Patients with positive hepatitis C antibody need to have a negative result for hepatitis C ribonucleic acid (RNA). Patients who are hepatitis C RNA positive will be excluded from participating in this trial
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the local investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness, in the judgement of the local investigator, including, but not limited to:
New York Heart Association (NYHA) class III or IV or symptomatic congestive heart failure
Unstable angina or acute coronary syndrome =\< 3 months prior to registration
Uncontrolled or symptomatic cardiac arrhythmia
NOTE: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker
Oxygen dependent baseline lung disease (such as interstitial lung disease or chronic obstructive pulmonary disease \[COPD\])
Ongoing inflammatory bowel disease (such as ulcerative colitis) requiring active treatment
Ongoing malabsorption syndrome or other condition that precludes enteral route of administration
Ongoing or active infection (viral, bacterial, or fungal)
Psychiatric illness/social situations that would limit compliance with study requirements
History of the following:
Cerebral vascular accident within 24 weeks prior to registration
Myocardial infarction within 24 weeks prior to registration
Major surgery =\< 28 days prior to registration
Live vaccination =\< 28 days prior to registration
Life-threatening thrombosis/embolism
Bleeding diathesis that precludes the use of low-dose aspirin (81 mg daily) or any form of anticoagulation
Other active primary malignancy (other than localized non-melanotic skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =\< 2 years NOTE: If there is a history of prior malignancy, the patient must be in remission not require ongoing therapy such as radiation, chemotherapy or immunotherapy for their cancer. Patients on adjuvant hormonal therapy for adequately treated nonmetastatic breast or prostate cancer are permitted if they meet other eligibility criteria
Unable to swallow oral drugs
What this trial measures
- Objective response rateUp to 5 years
A response is defined to be either a partial metabolic response (PMR) or complete metabolic response (CMR) by positron emission tomography (PET) or a partial response (PR) or complete response (CR) by computed tomography (CT) noted as the objective status using Lugano criteria. Objective response rate is defined as the proportion of evaluable patients who achieve response while on treatment. Estimate and corresponding 95% confidence intervals will be calculated according to the approach of Duffy and Santner.